Bioequivalence and Bioavailability Forum

Dear Jasmin

The regulatory option for waiver of the standard BE study in support of a parenteral drug requires that the drug product is a solution, and contains active and inactive ingredients in the same concentration as the reference drug product. In clear distinction to the types of products that could theoretically qualify for exemption of the standard BE study, colloidal suspension is not a true solution. The need to conduct a BE study should be individually discussed with the concerned regulatory agency.
Please refer to 21 CFR 320.22 and 21 CFR 320.33.

What therapeutic category does your product fall in?

thanks
biostar